Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia (FETO)

NCT03138863 | Recruiting DMC FDA Device

• 2 other identifiers: 20220033-116-008720
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to gather information on the safety and effectiveness of a new procedure called Fetoscopic Endoluminal Tracheal Occlusion (FETO).

Conditions

Congenital Diaphragmatic Hernia; Pulmonary Hypoplasia; Pulmonary Artery Hypertension

Keywords

fetal lungs; fetal surgery; congenital diaphragmatic hernia; tracheal occlusion; pulmonary hypoplasia

Outcome Measures

Primary Outcomes (6)

• Number of successfully completed FETO procedures

  The number of successful placement and removal of balloon during FETO procedure

  Up to 34 weeks gestation

• Operative time

  FETO placement and release operative times reported in minutes

  Up to 34 weeks gestation

• Frequency of unplanned balloon removal

  The frequency of non-emergent and emergent completion of FETO release (unplanned balloon removal)

  Up to 34 weeks gestation

• Number of incidences of maternal complications

  Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  Up to 41 weeks gestation

• Number of participants with maternal complications

  Maternal complications including preterm labor, premature rupture of membranes, oligohydramnios, polyhydramnios, chorioamnionitis

  Up to 41 weeks gestation

• Gestational Age at Delivery

  Gestation Age reported at time of delivery

  Up to 41 weeks gestation

Secondary Outcomes (13)

• Fetal Lung Growth as measured via Fetal Lung Volume

  Up to 41 weeks gestation

• Fetal Lung Growth as measured via LHR

  Up to 41 weeks gestation

• Fetal survival

  Up to 24 months post partum

• Number of newborns reported at each oxygen dependency grading

  Up to 24 months post partum

• Number of occurrence of severe pulmonary hypertension

  Up to 24 months post partum

Study Arms (1)

FETO Group

EXPERIMENTAL

Participants undergoing fetal endoscopic tracheal occlusion (FETO) surgery by insertion of the BALT GoldbBAL2 Detachable Balloon with the BALT catheter system.

Device: BALT GoldbBAL2 Detachable Balloon; Device: Catheter System

Interventions

BALT GoldbBAL2 Detachable Balloon DEVICE

Latex balloon, with radio-opaque inclusion

FETO Group

Catheter System DEVICE

100 cm tapered micro-catheter

Also known as: BALTACCIBDPE100

FETO Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Normal fetal karyotype with confirmation by culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks.
• Isolated Left CDH with liver up
• Gestation age at enrollment prior to 29 wks plus 6 days severe pulmonary hypoplasia with ultrasound (US) O/E lung area to head circumference ratio (LHR) \< 25% (measured at 180 to 296 weeks) at the time of surgery; O/E LHR 25% to \<30% (measured at 300 to 316 weeks) at time of surgery.
• Gestational age at FETO procedure with O/E LHR \<25% at 27 weeks 0 days to 29 weeks 6 days; with O/E LHR 25% to \<30% at 30 weeks 0 days to 31 weeks 6 days as determined by clinical information (LMP) and evaluation of first ultrasound
• Patient meets psychosocial criteria

You may not qualify if:

• Multi-fetal pregnancy
• History of natural rubber latex allergy
• Preterm labor, cervix shortened (\<15 mm at enrollment or within 24 hours of FETO balloon insertion procedure) or uterine anomaly strongly predisposing to preterm labor, placenta previa
• Psychosocial ineligibility, precluding consent:
• Inability to reside within 30 minute drive of our hospital, and inability to comply with the travel for the follow-up requirements of the trial
• Patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at our institution.
• Right sided CDH or bilateral CDH, isolated left sided with O/E LHR ≥30% (measured at 180 to 295 weeks) as determined by ultrasound
• Additional fetal anomaly and chromosomal abnormalities by ultrasound, MRI, or echocardiogram at the fetal treatment center. No cases will be removed post hoc if abnormalities are discovered in the course of postoperative monitoring
• Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy
• History of incompetent cervix with or without cerclage
• Placental abnormalities (previa, abruption, accrete) known at time of enrollment
• Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy
• Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment Uterine anomaly such as large or multiple fibroids or mullerian duct abnormality
• Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

Sponsors & Collaborators

• Rodrigo Ruano: lead

Study Sites (2)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

TERMINATED

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Familial Primary Pulmonary Hypertension

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Rodrigo Ruano, M.D., Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo A Ruano, MD, Ph.D

CONTACT

305.689.8001; rodrigo.ruano@miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief of MFM Division

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): November 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)